Pharmacovigilance is a scientific discipline which mainly pertains with identifying, validating, quantifying, evaluating and minimizing the adverse effects of therapeutic drugs, devices or biologics in order to increase their safety. The clinical research regulatory agencies worldwide including US FDA, Indian DCGI and EMEA etc., are strengthening the safety laws for adoption of a systematic pharmacovigilance framework. The adverse event data generated by clinical trials worldwide is enormous and has led to the outsourcing of the pharmacovigilance and pharmacoepidemiology services of the pharma-biotech Research and Development. This fact is compounded by the increasing number of local clinical trials has led to a spurt in the pharmacovigilance job market in India.
Clinical Research-Past, Present and Future, Drug development and discovery, Designing Clinical trials, Ethical issues in clinical Research, ICH-GCP Guidelines, Informed consent process: Protecting subjects Rights, Role of CRC and CRA in clinical Trials,Protocol Designing, Sponsor and investigator responsibilities, Pharmacovigilance in clinical research, Role of CRO in clinical research management, Biostatistics in clinical trails, Bioequivalence studies in clinical trails, Clinical data management, Clinical trials for herbal drugs and traditional medicines, Investigational new drug applications, Case report form, Standard operating procedures, Audit and inspection in clinical trails, Fraud and misconduct in clinical research, NDCT Rules replacement of schedule Y, Key definitions in Pharmacovigilance, Pharmacovigilance: Historical perspective, Pharmacovigilance need and objective, Current method of Pharmacovigilance, Adverse Drug Reaction: Classification, mechanism and interaction, Signal detection in Pharmacovigilance, Post meeting surveillance, Setting up of a Pharmacovigilance center,Benefit risk assessment in Pharmacovigilance, WHO programme for International drug monitoring, Pharmacovigilance of Herbal drugs, Medical Dictionary for Regulatory Activities, Pharmacogenetics and Pharmacovigilance, Pharmacovigilance regulations in various countries, Computer based system approach: Vigiflow software, Pharmacovigilance programme of India: Updates, ADR reporting forms used in India for Health care professionals, MEDWATCH Forms(US-FAD 3500 & 3500A), Yellow card system in UK, Pharmacovigilance system Australia,Blue card : Australia, Pharmacovigilance system Canada, ADR forms Canada, Pharmacovigilance system Japan, Pharmacovigilance system china, Haemovigilance programme of India, Materiovigilance Programme of India, Serious AEFI Case notification form, Toll free no used for ADR Reporting, Mobile app used for ADR Reporting, Suspected ADR Reporting Form for Drugs used in Covid-19, Partners Roles and Responsibilities in Ensuring Vaccines Safety, ADR Reporting Form for Consumers in Hindi & other Vernacular Languages
IBRI offers a wide range of programmes in Pharmacovigilance
- Global Pharmacovigilance - Case Processing - ICSRs; Aggregate Reporting; Risk Management & Signal Detection;
Pharmacovigilance Audits & Inspections; Pharmacovigilance Regulatory; Medical Review, Safety Databases and many more areas
- Clinical Research / Clinical Trials - Clinical Trials Management; GCP Training; Investigator Training, CRA - Clinical Research Associate, CRC - Clinical Research Coordinator and over 30 modules in clinical research
- Medical and Scientific Writing
- Drug / Pharma Regulatory Affairs
As Pharmacovigilance and Clinical Research are becoming an important part of drug development as it deals with the patient’s safety keeping this in mind IBRI has introduced certificate course in Pharmcovigilance.
||Principles of Pharmacovigilance
||Methodologies in Pharmacovigilance and Signal Detection
||Pharmacovigilance Compliance and Management
||Pharmacovigilance Regulations and Guidelines